On February 19, 2014, China’s State Council Legislative Affairs Office released a revised draft amendment to the Drug Registration Regulation (DRR). Public comments are due by March 23, 2014. The revised draft updates the draft DRR amendment that CFDA published for comment in November 2013 (see China CFDA Amending its Drug Registration Regulation).
Most noteworthy in this revised draft amendment is the retention of part of old Article 19 of the DRR, which CFDA had earlier proposed to delete. Original Article 19 requires CFDA to (i) accept generic filings two years before expiration of the relevant patents of the innovative drug, and (ii) issue market approvals to generic manufacturers only after the relevant patents expire. In the revised draft, the two-year window for generic filings is eliminated, permitting generic manufacturers to file applications and CFDA to accept and review such applications any time during the relevant patent terms.
A new requirement is also added to the revised Article 19, however, under which generic drug approvals issued by CFDA “will only become effective upon expiration of the relevant patents.” This is a significant development for the protection of patented drugs. If finalized, it would work in tandem with the China patent linkage system under which generic versions of a patented drug may not be manufactured in China until the relevant patents expire.
Given the potential impact of these changes on regulatory strategy and requirements in China, companies should carefully review the revised draft amendment to the DRR and submit comments by the March 23 deadline.